Clearance Summary
DUAL LUMEN CATHETER FOR CHRONIC VASCULAR ACCESS received FDA 510(k) clearance under submission number K892926, sponsored by Vas-Cath, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1989-12-05.
- Submission: K892926
- Applicant / Sponsor: Vas-Cath, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5970
- Decision date: 1989-12-05
Classification & Regulation
This clearance is catalogued under FDA product code LJS and 21 CFR 880.5970, within the General Hospital review panel as a Class II device.